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NCT03165526 · ClinicalTrials.gov registry record
The AMPLATZER™ Post-infarct Muscular VSD Occluder Humanitarian Device Exemption (H070005) Post Approval Study
A clinical trial, sponsored by Abbott Medical Devices.
- Completed
- Registry status
- 131
- Enrollment target
NCT03165526 is a clinical trial that has completed, run by Abbott Medical Devices. The registered enrollment target is 131 participants.
The verdict
NCT03165526 has completed, sponsored by Abbott Medical Devices.
- COMPLETED
- Registry status
- 131 participants
- Enrollment target
Study Summary
FDA issued a Humanitarian Device Exemption (HDE) approval order for the AMPLATZER™ PIVSD Occluder (H070005) on January 10, 2017. The Conditions of Approval require that SJM conduct a post approval study to evaluate the safety and probable benefit of the AMPLATZER™ PIVSD Occluder.
Interventions
- DEVICE AMPLATZER™ Post-infarct Muscular VSD Occluder
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 131 participants |
| Start Date | 2018-10-01 |
| Est. Completion | 2021-11-29 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03165526
The ClinicalTrials.gov registry entry for NCT03165526 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 131 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Abbott Medical Devices, which has 261 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which AMPLATZER™ Post-infarct Muscular VSD Occluder is the first listed.
NCT03165526 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03165526 about?
NCT03165526 is a clinical study titled "The AMPLATZER™ Post-infarct Muscular VSD Occluder Humanitarian Device Exemption (H070005) Post Approval Study". FDA issued a Humanitarian Device Exemption (HDE) approval order for the AMPLATZER™ PIVSD Occluder (H070005) on January 10, 2017. The Conditions of Approval require that SJM conduct a post approval study to evaluate the safety and probable benefit of the AMPLATZER™ PIVSD Occluder.
What is the current status of trial NCT03165526?
This trial is currently completed. The enrollment target is 131 participants. The study started on 2018-10-01. Estimated completion is 2021-11-29.
What interventions are being tested in trial NCT03165526?
The interventions under investigation include: AMPLATZER™ Post-infarct Muscular VSD Occluder (DEVICE).
Who is sponsoring clinical trial NCT03165526?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
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